Adjustment With Aphasia After Stroke: SUPERB
"SUPERB"

Recruiting

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Update History

2 Aug '17

The Summary of Purpose was updated.

New

Aims: This exploratory trial will:
1. Explore the feasibility of a definitive/phase III RCT on clinical and cost-effectiveness
of peer-befriending for people with aphasia post-stroke.
2. Investigate psychological and social wellbeing outcomes of participants, significant
others, and peer befrienders.
3. Explore the feasibility of a full economic evaluation of usual care + peer befriending
versus usual care control.
Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care +
peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver
on four work packages: development phase; RCT; qualitative study; economic evaluation.
Participants (n=60) will be assessed three times up to 10 months post-randomisation.
Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion
screened who meet criteria; proportion who consent; rate of consent); participant,
significant other, peer befriender views on acceptability of procedures (qualitative study);
number of missing/incomplete data on outcome measures; attrition rate at follow-up; potential
value of conducting main trial using value of information analysis (economic evaluation);
description of usual care; treatment fidelity of peer-befriending. Patient-reported outcomes
will include mood, wellbeing, communication and social participation.
Benefits: Peer befriending may help avert some of the serious psychological consequences of
stroke, and prevent the need for more complex and costly psychological therapies.

Old

Aims: This exploratory trial will:
1. Explore the feasibility of a definitive/phase III RCT on clinical and
cost-effectiveness of peer-befriending for people with aphasia post-stroke.
2. Investigate psychological and social wellbeing outcomes of participants, significant
others, and peer befrienders.
3. Explore the feasibility of a full economic evaluation of usual care + peer befriending
versus usual care control.
Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care +
peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver
on four work packages: development phase; RCT; qualitative study; economic evaluation.
Participants (n=60) will be assessed three times up to 10 months post-randomisation.
Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion
screened who meet criteria; proportion who consent; rate of consent); participant,
significant other, peer befriender views on acceptability of procedures (qualitative study);
number of missing/incomplete data on outcome measures; attrition rate at follow-up;
potential value of conducting main trial using value of information analysis (economic
evaluation); description of usual care; treatment fidelity of peer-befriending.
Patient-reported outcomes will include mood, wellbeing, communication and social
participation.
Benefits: Peer befriending may help avert some of the serious psychological consequences of
stroke, and prevent the need for more complex and costly psychological therapies.

Background: Stroke and aphasia can have a profound impact on people's lives. Depression is a
common sequel of stroke, with rates remaining high even one year after stroke at 33%. It is
associated with worse rehabilitation outcomes, increased carer strain, increased healthcare
utilisation, and higher mortality. A recent audit of clinical psychology services for people
with mood problems post-stroke across 10 UK stroke services found that the most common
outcome of mood assessment was monitoring and advice, with less than half of patients with
low mood receiving psychological intervention. There is a pressing need to evaluate
systematically interventions that aim to improve psychosocial wellbeing for people with
stroke and aphasia.
Aims: SUPERB trial aims to evaluate the feasibility of a phase III trial on the clinical and
cost-effectiveness of a stepped care model level 1 intervention, peer befriending, for people
with aphasia. Specifically it will:
1. Explore the feasibility of a definitive phase III randomised control trial (RCT) based
on a) feasibility of recruitment and retention to the trial, b) acceptability of
research procedures and outcome measures, c) acceptability of usual care + peer
befriending vs. usual care control to participants, their significant others and peer
support workers, d) documentation of usual care, e) treatment fidelity of peer
befriending.
2. Explore psychological and social well-being outcomes as outcomes in a definitive trial
for a) people with aphasia receiving usual care + peer befriending versus usual care
control, b) their significant others, and c) peer befrienders.
3. Explore the feasibility of a full economic evaluation of usual care + peer befriending
versus usual care control in a phase III RCT.
Intervention to be tested: The intervention group will receive peer befriending from stroke
survivors with long-term aphasia who will be trained as peer befrienders. They will visit
participants who have had a stroke more recently 6 times over a period of 3 months. An
further 2 visits within the next 6 months will also be offered for a gradual transition to
the end of the peer befriending. The schedule and nature of visits will be agreed between the
pair at their first meeting. This meeting will also identify possible goals for the
intervention e.g. to offer conversation, help with problem solving and social activities.
Methods: The overall study will last 3½ years and comprise a development phase (year 1) and a
phase II RCT (years 2-3). The development phase will inform the intervention manual, the
choice of outcome measures, fidelity practices and topic guides for participant interviews.
This phase will be informed through a series of six workshops attended by six people with
aphasia with experience of peer befriending. This will be followed by a pilot of the
intervention, fidelity checking and all associated processes with 8 participants comparing
usual care (n=4) with usual care + peer befriending (n=4).
The phase II RCT will be a single blind, mixed methods, parallel group design comparing usual
care (n=30) with usual care + peer befriending (n=30) for people with aphasia post-stroke and
low levels of psychological problems. Assessments and outcome measures for participants and
significant others will be administered before randomisation with outcome measures
re-administered at 4 and 10 months post-randomisation. Peer befrienders will complete outcome
measures before training and after they have completed the visits for two participants. In
addition, this RCT will include a qualitative study and a feasibility economic evaluation.
The qualitative study will use semi-structured interviews of purposively sampled participants
(n=20) and significant others (n=10) from both arms of the trial, and peer befrienders. The
feasibility economic evaluation will utilise the EQ-5D and a stroke-adapted version of the
CSRI.
Outcomes: RCT: feasibility of recruitment of participants to definitive trial (including
proportion screened who meet criteria; proportion who consent; rate of consent); number of
missing/incomplete data on outcome measures; attrition rate at follow-up; potential value of
conducting main trial using value of information analysis (economic evaluation); description
of usual care; treatment fidelity of peer befriending. Patient-reported outcomes will include
mood, wellbeing, communication and social participation. Qualitative study: participant,
significant other, peer befriender views on acceptability of procedures and experiences of
care received. Economic evaluation: cost outcomes, average costs, costs per participant and
mean difference between trial arms, description of resources used and overall cost
effectiveness.
Benefits: This study will inform on whether peer befriending is a suitable intervention to
explore further, in terms of averting some of the serious psychological consequences of
stroke, and preventing the need for more complex and costly psychological therapies.

Old

Background: Stroke and aphasia can have a profound impact on people's lives. Depression is a
common sequel of stroke, with rates remaining high even one year after stroke at 33%. It is
associated with worse rehabilitation outcomes, increased carer strain, increased healthcare
utilisation, and higher mortality. A recent audit of clinical psychology services for people
with mood problems post-stroke across 10 UK stroke services found that the most common
outcome of mood assessment was monitoring and advice, with less than half of patients with
low mood receiving psychological intervention. There is a pressing need to evaluate
systematically interventions that aim to improve psychosocial wellbeing for people with
stroke and aphasia.
Aims: SUPERB trial aims to evaluate the feasibility of a phase III trial on the clinical and
cost-effectiveness of a stepped care model level 1 intervention, peer befriending, for
people with aphasia. Specifically it will:
1. Explore the feasibility of a definitive phase III randomised control trial (RCT) based
on a) feasibility of recruitment and retention to the trial, b) acceptability of
research procedures and outcome measures, c) acceptability of usual care + peer
befriending vs. usual care control to participants, their significant others and peer
support workers, d) documentation of usual care, e) treatment fidelity of peer
befriending.
2. Explore psychological and social well-being outcomes as outcomes in a definitive trial
for a) people with aphasia receiving usual care + peer befriending versus usual care
control, b) their significant others, and c) peer befrienders.
3. Explore the feasibility of a full economic evaluation of usual care + peer befriending
versus usual care control in a phase III RCT.
Intervention to be tested: The intervention group will receive peer befriending from stroke
survivors with long-term aphasia who will be trained as peer befrienders. They will visit
participants who have had a stroke more recently 6 times over a period of 3 months. An
further 2 visits within the next 6 months will also be offered for a gradual transition to
the end of the peer befriending. The schedule and nature of visits will be agreed between
the pair at their first meeting. This meeting will also identify possible goals for the
intervention e.g. to offer conversation, help with problem solving and social activities.
Methods: The overall study will last 3½ years and comprise a development phase (year 1) and
a phase II RCT (years 2-3). The development phase will inform the intervention manual, the
choice of outcome measures, fidelity practices and topic guides for participant interviews.
This phase will be informed through a series of six workshops attended by six people with
aphasia with experience of peer befriending. This will be followed by a pilot of the
intervention, fidelity checking and all associated processes with 8 participants comparing
usual care (n=4) with usual care + peer befriending (n=4).
The phase II RCT will be a single blind, mixed methods, parallel group design comparing
usual care (n=30) with usual care + peer befriending (n=30) for people with aphasia
post-stroke and low levels of psychological problems. Assessments and outcome measures for
participants and significant others will be administered before randomisation with outcome
measures re-administered at 4 and 10 months post-randomisation. Peer befrienders will
complete outcome measures before training and after they have completed the visits for two
participants. In addition, this RCT will include a qualitative study and a feasibility
economic evaluation. The qualitative study will use semi-structured interviews of
purposively sampled participants (n=20) and significant others (n=10) from both arms of the
trial, and peer befrienders. The feasibility economic evaluation will utilise the EQ-5D and
a stroke-adapted version of the CSRI.
Outcomes: RCT: feasibility of recruitment of participants to definitive trial (including
proportion screened who meet criteria; proportion who consent; rate of consent); number of
missing/incomplete data on outcome measures; attrition rate at follow-up; potential value of
conducting main trial using value of information analysis (economic evaluation); description
of usual care; treatment fidelity of peer befriending. Patient-reported outcomes will
include mood, wellbeing, communication and social participation. Qualitative study:
participant, significant other, peer befriender views on acceptability of procedures and
experiences of care received. Economic evaluation: cost outcomes, average costs, costs per
participant and mean difference between trial arms, description of resources used and
overall cost effectiveness.
Benefits: This study will inform on whether peer befriending is a suitable intervention to
explore further, in terms of averting some of the serious psychological consequences of
stroke, and preventing the need for more complex and costly psychological therapies.

Inclusion Criteria:
Participants with aphasia:
- Over 18;
- Fluent premorbid users of English (confirmed by relative or self report);
- Presence of aphasia due to stroke; and
- Low levels of emotional distress (score of ≤2 on Depression Intensity Scale Circles).
The latter will ensure that they do not require immediate level 2 or 3 psychological
input. People who score 2 (which is also the median on DISCS) and who the MDT deems do
not need stepping up or stepping up is not available, will still be eligible to take
part.
Significant Others: each participant with aphasia will nominate one significant other, who
is their closest confidant and who is over 18 years of age. If participants live alone
their significant other should be someone that they see at least once a week.
Peer befrienders: will be people with mild-moderate aphasia (score score a minimum 5/10 for
auditory comprehension and 5/10 for verbal expression in the Frenchay Aphasia Screening
Test) who are over 18 years of age, are at least one year post-stroke
Exclusion Criteria:
Participants will be excluded if they have:
- Other diagnoses affecting cognition or mental health (based on medical records for
participants with aphasia and self-report for significant others and peer befrienders,
as well as the GHQ-12 as a depression screen for peer befrienders: will be excluded if
they score 3 or more);
- Severe uncorrected visual or hearing problems (based on medical records for
participants with aphasia and self-report for significant others and peer
befrienders);
- Severe or potentially terminal co-morbidities, on grounds of frailty (based on medical
records for participants with aphasia and self-report for significant others and peer
befrienders).
Participants with aphasia will also be excluded if they are:
• Discharged to a geographical location outside the borough of the recruiting hospital.

Old

Inclusion Criteria:
Participants with aphasia:
- Over 18;
- Fluent premorbid users of English (confirmed by relative or self report);
- Presence of aphasia due to stroke; and
- Low levels of emotional distress (score of ≤2 on Depression Intensity Scale Circles).
The latter will ensure that they do not require immediate level 2 or 3 psychological
input. People who score 2 (which is also the median on DISCS) and who the MDT deems
do not need stepping up or stepping up is not available, will still be eligible to
take part.
Significant Others: each participant with aphasia will nominate one significant other, who
is their closest confidant and who is over 18 years of age. If participants live alone
their significant other should be someone that they see at least once a week.
Peer befrienders: will be people with mild-moderate aphasia (score score a minimum 5/10
for auditory comprehension and 5/10 for verbal expression in the Frenchay Aphasia
Screening Test) who are over 18 years of age, are at least one year post-stroke
Exclusion Criteria:
Participants will be excluded if they have:
- Other diagnoses affecting cognition or mental health (based on medical records for
participants with aphasia and self-report for significant others and peer
befrienders, as well as the GHQ-12 as a depression screen for peer befrienders: will
be excluded if they score 3 or more);
- Severe uncorrected visual or hearing problems (based on medical records for
participants with aphasia and self-report for significant others and peer
befrienders);
- Severe or potentially terminal co-morbidities, on grounds of frailty (based on
medical records for participants with aphasia and self-report for significant others
and peer befrienders).
Participants with aphasia will also be excluded if they are:
• Discharged to a geographical location outside the borough of the recruiting hospital.

A location was updated in London.

New

The overall status was updated to "Recruiting" at The Royal London Hospital.

A location was updated in London.

New

The overall status was updated to "Recruiting" at Homerton University Hospital.

A location was updated in London.

New

The overall status was updated to "Recruiting" at University College London Hospital.

A location was updated in London.

New

The overall status was updated to "Recruiting" at The Royal Free Hospital.

A location was updated in London.

New

The overall status was updated to "Recruiting" at The National Hospital for Neurology and Neurosurgery.

Professionals

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This project is supported in part by the NIH Specialized Programs of Translational Research in Acute Stroke (SPOTRIAS) Network, and NINDS grant 3P50NS055977 to Washington University in St. Louis School of Medicine and UT Southwestern Medical Center.